UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059769 |
|---|---|
| Receipt number | R000068347 |
| Scientific Title | Evaluation of the Anesthetic Efficacy of the New Tenon's Capsule Subcapsular Injection Needle in Simultaneous Cataract and Vitrectomy Surgery |
| Date of disclosure of the study information | 2025/11/13 |
| Last modified on | 2025/11/13 17:29:51 |
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Basic information
Public title
Evaluation of the Anesthetic Efficacy of the New Tenon's Capsule Subcapsular Injection Needle in Simultaneous Cataract and Vitrectomy Surgery
Acronym
Evaluation of the Anesthetic Efficacy of the New Tenon's Capsule Subcapsular Injection Needle in Simultaneous Cataract and Vitrectomy Surgery
Scientific Title
Evaluation of the Anesthetic Efficacy of the New Tenon's Capsule Subcapsular Injection Needle in Simultaneous Cataract and Vitrectomy Surgery
Scientific Title:Acronym
Evaluation of the Anesthetic Efficacy of the New Tenon's Capsule Subcapsular Injection Needle in Simultaneous Cataract and Vitrectomy Surgery
Region
| Japan |
Condition
Condition
Cases Indicated for Simultaneous Cataract and Vitrectomy Surgery
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to determine whether Tenon's capsule anesthesia using the new 25G sub-Tenon injection needle enables stable pain control throughout surgery.
Conventional Tenon's capsule anesthesia needles had design limitations, but this product eliminates the need for conjunctival incision, promising reduced complications and improved operability. This research provides insights into its anesthetic efficacy and safety.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Is the pain score at the end of cataract surgery comparable to the pain score at the end of surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
After cataract surgery under topical anesthesia, Tenon's capsule anesthesia (2% lidocaine, 3 mL) is administered, followed by 25-gauge vitrectomy. The patient is evaluated for pain, ocular motility, eyelid movement, and the presence of anesthesia-related complications.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients aged 40 years or older scheduled for simultaneous cataract and vitrectomy surgery
Patients who have provided written consent
Key exclusion criteria
Patients with ocular motor disorders
Proliferative disease with proliferative membranes extending beyond two quadrants
Hypersensitivity to local anesthetics
Patients with a history of surgery at the same site
Patients unable to verbally report NRS scores
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Koto |
Organization
Kyorin University School of Medicine
Division name
Department of Ophthalmology
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
TEL
0422475511
koto@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Koto |
Organization
Kyorin University School of Medicine
Division name
Department of Ophthalmology
Zip code
1818611
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
TEL
0422475511
Homepage URL
koto@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyorin University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
School of Medicine Research Ethics Committee, Kyorin University
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
Tel
0422475511
rec@ks.kyorin-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 13 | Day |
Last modified on
| 2025 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068347
